What does risk analysis in medical device development typically include?

Risk analysis in medical device development is a crucial process that focuses on identifying potential hazards associated with the device. This involves a systematic evaluation of what might go wrong during the use of the device, considering factors such as the design, materials, manufacturing processes, and intended use. The goal is to understand and mitigate risks to ensure the safety and efficacy of the device for patients and users.

This assessment typically leads to the development of risk management plans that outline strategies for mitigating identified risks, such as implementing design changes or adding safety features. By prioritizing safety from the outset, manufacturers can comply with regulatory standards and reduce the likelihood of adverse events once the device is on the market.

In contrast, aspects like marketing, regulating prices, and designing interfaces, while important to the overall lifecycle of a medical device, do not fall under the purview of risk analysis. These activities occur at different stages and with different focuses, primarily involving business and usability considerations rather than safety and hazard identification.